Biological Scientist II-GMP Lab

University of Florida•Gainesville, FL

7d•$61,350 - $69,700•Onsite

About The Position

This position is responsible for executing cell processing procedures in accordance with approved SOPs, batch records, and GMP requirements. The role involves performing aseptic processing, cell culture, expansion, cryopreservation, thawing, and formulation activities. Additionally, the Biological Scientist II will prepare reagents, materials, and equipment for manufacturing runs, and maintain cleanroom standards, gowning compliance, and contamination control practices. The role also requires accurate and contemporaneous completion of batch records, logbooks, and GMP documentation, participation in deviation reporting, CAPA support, and change control implementation. Maintaining compliance with cGMP, institutional, and regulatory requirements is crucial. The position involves recording and maintaining detailed research procedures and results, following Good Documentation Practices (GDP), and maintaining audit-ready records. Training activities for co-workers and junior staff are also part of the responsibilities, along with performing scheduled tasks requiring strict adherence to SOPs with meticulous reporting and data entry. Quality control and analytical testing for cell therapy product release, including flow cytometry, ELISA, endotoxin, and Gram Stains, will be performed. This includes assisting with in-process monitoring and sample preparation, analyzing resulting data using statistical models, and documenting test results to ensure traceability in compliance with GMP requirements.

Requirements

Bachelor's degree in biology or a related field and three years of experience or Master's degree in biology or a related field with one year of relevant experience.
Strong aseptic technique.
High attention to detail and documentation accuracy.
Ability to follow complex written procedures precisely.
Understanding of chain-of-identity and chain-of-custody principles
Team-oriented with strong communication skills.
Ability to work in a fast-paced clinical manufacturing environment.
Proficient in Office Suite software.

Nice To Haves

Prior experience in small- to intermediate-scale cell therapy manufacturing under GMP conditions strongly preferred.
Familiarity with autologous cell therapy manufacturing workflows is highly desirable.
Experience with aseptic technique in ISO-classified cleanroom environments.
Working knowledge of cGMP regulations and documentation practices.
Understanding of Quality Control processes and basic analytical testing methods.
Experience with flow cytometry, cell counting systems, or other cell-based analytical assays is a plus.
Prior hands-on experience in clinical-stage cell therapy manufacturing under GMP conditions.
A working understanding of quality control principles, and basic analytical testing skills to support in-process monitoring and product release activities.

Responsibilities

Execute cell processing procedures in accordance with approved SOPs, batch records, and GMP requirements
Perform aseptic processing, cell culture, expansion, cryopreservation, thawing, and formulation activities.
Prepare reagents, materials, and equipment required for manufacturing runs.
Maintain cleanroom standards, gowning compliance, and contamination control practices.
Accurately complete batch records, logbooks, and GMP documentation contemporaneously.
Participate in deviation reporting, CAPA support, and change control implementation.
Maintain compliance with cGMP, institutional, and regulatory requirements.
Record and maintain detailed research procedures and results.
Follow Good Documentation Practices (GDP) and maintain audit-ready records.
Participate in training activities for co-workers and junior staff.
Perform scheduled tasks requiring strict adherence to SOPs with meticulous reporting and data entry.
Perform analytical testing for cell therapy product release including flow cytometry, ELISA, endotoxin, Gram Stains and related assays.
Assist with in-process monitoring and sample preparation.
Analyze resulting data using statistical models to ensure product quality and process consistency.
Document test results and ensure traceability in compliance with GMP requirements.